Manufacturer
Xi'An Taibo Electronic Technology Co., Ltd.808nm semiconductor laser hair removal machine
Xi'An Taibo Electronic Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K252048
- Device name
- 808nm semiconductor laser hair removal machine
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-06-30
- Decision date
- 2026-02-03
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The 808nm Semiconductor laser hair removal machine is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Intended Use
The 808nm Semiconductor laser hair removal machine is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Device Description
This 808nm semiconductor laser hair removal machine adopts 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. The Medical Diode Laser Hair Removal System utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handpiece. The emission laser is activated by a foot-switch. This 808nm semiconductor laser hair removal machine consists of laser power supply, laser treatment handle, host controller, liquid crystal controller (operating system) water cooling system, low voltage control circuit and fault alarm system. Accessories include water filling funnel, overflow plug, foot switch, bracket, key, laser protection goggles (operator wearing), protective eye wear (patient wearing), power line, fuse, user manual and packing list.
Summary parsed at:2026-06-01 05:18:33 UTC
Predicate devices
2Diode Laser Therapy Systems
Medical Diode Laser Hair Removal System (MNLT-D1)
K252048 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252048 as a predicate
